THE COVID-19 IGG/IGM RAPID TEST CASSETTE

ABOUT THE ORIENT GENE RAPID TEST

This is a lateral flow assay based test, that uses human venous whole blood, plasma from anticoagulated blood, or serum to detect IgG and IgM antibodies. The test takes approximately 10 minutes and is a qualitative test for presence of antibodies. Sensitivity was determined from 90 positive clinical samples and specificity from 101 negative clinical samples from two testing sites in China. The test was also independently validated, with a sensitivity of 95% and specificity of 100%.

EXECUTION OF THE RAPID TEST

1. Remove the test cassette from the sealed foil pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour.
2. Place the test device on a clean and level surface.
For Serum or Plasma Specimens:
With a 5 μL mini plastic dropper provided, draw serum/plasma specimen to exceed the specimen line as shown in the following image and then transfer drawn serum/plasma specimen into the sample well ( S ). Then add 2 drops (about 80μL) of sample buffer to the buffer well ( B ) immediately. Avoid air bubbles.
Note: Practice a few times prior to testing if you are not familiar with the mini dropper. For better precision, transfer specimen by pipette capable to deliver 5 μL of volume.
For Whole Blood Specimen: 
Hold the 5 μL mini plastic dropper vertically and transfer 1 drop of whole blood (about 10μL) to the specimen well(S) of the test device, then add 2 drops (about 80μL) of sample buffer to the buffer well ( B ) immediately. Avoid air bubbles.
3. Wait for the colored line(s) to appear. After 2 minutes, if the red colour has not moved across the test window or if blood is still present in the specimen well (S), add 1 additional drop of the sample buffer to the buffer well ( B ).
4. The result should be read in 10 minutes. Positive results may be visible as soon as 2 minutes. Do not interpret the result after 15 minutes.

THE RESULT

NEGATIVE: The colored line in the control line region (C) changes from blue to red. No line appears in the test line regions M or G. The result is negative.

IgM POSITIVE:

The colored line in the control line region (C) changes from blue to red, and a colored line appears in test line region M. The result is anti-COVID-19 IgM positive.

IgG POSITIVE:

The colored line in the control line region (C) changes from blue to red, and a colored line appears in test line region G. The result is anti-COVID-19 IgG positive.

IgG and IgM POSITIVE:

The colored line in the control line region (C) changes from blue to red, and two colored lines appear in test line regions M and G. The result is anti-COVID-19 IgM and IgG positive.

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INVALID:

The Control line is still completely or partially blue and fails to completely change from blue to red. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test cassette.